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    Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N) (NCT05582499)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    12/27/2024
    Initiation :
    11/01/2022
    Primary completion :
    12/31/2024
    Completion :
    09/01/2025
    HER-2 • PGR • CD8 • FOXC1
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Ariely (adebrelimab) • tizetatug rezetecan (SHR-A1921)
    Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (OBU-BC-II-164) (NCT06650748)
    Phase 2
    Peking University
    Not yet recruiting
    Last update posted :
    10/26/2024
    Initiation :
    11/15/2024
    Primary completion :
    10/01/2027
    Completion :
    04/01/2028
    CDK4
    |
    letrozole • AiRuiKang (dalpiciclib)
    Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES) (NCT05861830)
    Phase 3
    Peking Union Medical College Hospital
    Recruiting
    Last update posted :
    03/12/2024
    Initiation :
    05/15/2023
    Primary completion :
    12/31/2025
    Completion :
    06/30/2026
    HER-2 • ER
    |
    ER positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    carboplatin • paclitaxel • tamoxifen • capecitabine • fulvestrant • AiRuiKang (dalpiciclib)
    A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (NCT06208410)
    Phase 1/2
    Risen (Suzhou) Pharma Tech Co., Ltd.
    Recruiting
    Last update posted :
    03/08/2024
    Initiation :
    01/11/2024
    Primary completion :
    02/26/2026
    Completion :
    02/26/2026
    PIK3CA
    |
    PIK3CA mutation
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • capecitabine • Irene (pyrotinib) • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer (NCT05574881)
    Phase 1/2
    Fudan University
    Active, not recruiting
    Last update posted :
    02/26/2024
    Initiation :
    09/01/2022
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    HER-2 • ER • PGR
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • fulvestrant • AiRuiKang (dalpiciclib)
    Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02 (NCT05205200)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    02/08/2024
    Initiation :
    06/06/2022
    Primary completion :
    02/01/2025
    Completion :
    08/01/2026
    HER-2 • ER • PGR • SMARCA2
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    albumin-bound paclitaxel • fulvestrant • AiRuiKang (dalpiciclib) • Ariely (adebrelimab)
    Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer (BCTOP-L-M01) (NCT05949541)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    02/08/2024
    Initiation :
    07/26/2023
    Primary completion :
    07/01/2026
    Completion :
    01/01/2028
    HER-2
    |
    HER-2 negative
    |
    everolimus • fulvestrant • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate
    SNF Platform Study of HR+/ HER2-advanced Breast Cancer (BCTOP-L-M05) (NCT05594095)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    02/06/2024
    Initiation :
    12/30/2022
    Primary completion :
    12/01/2025
    Completion :
    12/01/2026
    HER-2 • ER • PGR
    |
    ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive
    |
    sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020)
    PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer (NCT05759546)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    02/06/2024
    Initiation :
    02/01/2023
    Primary completion :
    11/01/2025
    Completion :
    06/01/2027
    HER-2 • ER • PGR
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer (BCTOP-L-M04) (NCT05759572)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    02/06/2024
    Initiation :
    02/01/2023
    Primary completion :
    11/01/2025
    Completion :
    06/01/2027
    HER-2 • ER • PGR
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    AiTan (rivoceranib) • fulvestrant • AiRuiKang (dalpiciclib)
    Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER) (NCT05640778)
    Phase 2
    Second Affiliated Hospital, School of Medicine,...
    Recruiting
    Last update posted :
    01/31/2024
    Initiation :
    10/01/2022
    Primary completion :
    10/31/2024
    Completion :
    10/31/2025
    HER-2
    |
    HR positive
    |
    cyclophosphamide • AiRuiKang (dalpiciclib)
    Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment (NCT05132790)
    Phase N/A
    Shengjing Hospital
    Active, not recruiting
    Last update posted :
    01/03/2024
    Initiation :
    09/25/2023
    Primary completion :
    12/31/2024
    Completion :
    12/31/2028
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative
    |
    cisplatin • carboplatin • albumin-bound paclitaxel • AiRuiKang (dalpiciclib) • Ariely (adebrelimab)
    A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (NCT03481998)
    Phase 1/2
    Jiangsu HengRui Medicine Co., Ltd.
    Completed
    Last update posted :
    11/21/2023
    Initiation :
    03/22/2018
    Primary completion :
    07/30/2022
    Completion :
    07/30/2022
    HER-2
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • letrozole • anastrozole • AiRuiKang (dalpiciclib)
    Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial. (NCT06133088)
    Phase 2
    Zhejiang Cancer Hospital
    Recruiting
    Last update posted :
    11/15/2023
    Initiation :
    08/01/2023
    Primary completion :
    12/31/2024
    Completion :
    08/31/2025
    CDK6 • LRPPRC
    |
    fulvestrant • AiRuiKang (dalpiciclib) • R-(-)-gossypol (AT 101)
    Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC） (NCT06107673)
    Phase 2
    Hebei Medical University Fourth Hospital
    Recruiting
    Last update posted :
    10/30/2023
    Initiation :
    09/30/2023
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    HER-2 • ER
    |
    HER-2 negative
    |
    cyclophosphamide • epirubicin • AiRuiKang (dalpiciclib)
    Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02) (NCT05328440)
    Phase 2
    Henan Cancer Hospital
    Recruiting
    Last update posted :
    09/25/2023
    Initiation :
    05/20/2022
    Primary completion :
    06/01/2024
    Completion :
    01/01/2026
    HER-2 • ER • PGR
    |
    ER negative • EGFR positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • fulvestrant • AiRuiKang (dalpiciclib) • Cipterbin (inetetamab)
    Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy (NCT05979220)
    Phase 2
    Shuangyue Liu
    Not yet recruiting
    Last update posted :
    08/07/2023
    Initiation :
    12/01/2023
    Primary completion :
    06/30/2024
    Completion :
    06/30/2028
    HER-2
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    letrozole • AiRuiKang (dalpiciclib)
    Phase Ib/II Study of Fluzoparib in Combination With Dalpiciclib in Patients With Locally Advanced or Metastatic Sarcoma (NCT05952128)
    Phase 2
    Sun Yat-sen University
    Recruiting
    Last update posted :
    07/19/2023
    Initiation :
    07/01/2023
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    BRCA
    |
    AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer (DAP-Her-01) (NCT04293276)
    Phase 2
    Henan Cancer Hospital
    Active, not recruiting
    Last update posted :
    05/04/2023
    Initiation :
    04/01/2020
    Primary completion :
    08/23/2021
    Completion :
    05/01/2023
    HER-2
    |
    HER-2 positive
    |
    Irene (pyrotinib) • AiRuiKang (dalpiciclib)
    Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer (NCT05176080)
    Phase 1/2
    Henan Cancer Hospital
    Active, not recruiting
    Last update posted :
    05/04/2023
    Initiation :
    12/08/2021
    Primary completion :
    05/30/2024
    Completion :
    01/30/2026
    HER-2
    |
    HR positive • HER-2 negative
    |
    fulvestrant • AiRuiKang (dalpiciclib) • famitinib (SHR 1020)
    A Study of SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer. (NCT04733417)
    Phase 2
    Tianjin Medical University Cancer Institute and...
    Active, not recruiting
    Last update posted :
    04/12/2023
    Initiation :
    05/26/2021
    Primary completion :
    08/30/2022
    Completion :
    09/30/2023
    HER-2
    |
    HER-2 negative
    |
    AiRuiKang (dalpiciclib) • famitinib (SHR 1020)
    SHR6390 Combined With Anastrozole for Preoperative Treatment of Breast Cancer. (NCT04836520)
    Phase 2
    Tianjin Medical University Cancer Institute and...
    Completed
    Last update posted :
    04/12/2023
    Initiation :
    08/02/2021
    Primary completion :
    02/28/2023
    Completion :
    03/31/2023
    HER-2
    |
    HER-2 negative
    |
    anastrozole • AiRuiKang (dalpiciclib)
    Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer (NCT05463601)
    Phase 2
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Un...
    Recruiting
    Last update posted :
    04/12/2023
    Initiation :
    08/01/2022
    Primary completion :
    12/01/2023
    Completion :
    12/01/2024
    HER-2
    |
    HER-2 negative
    |
    tamoxifen • fulvestrant • letrozole • exemestane • AiRuiKang (dalpiciclib) • Pegylated rhG-CSF (mecapegfilgrastim)
    Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy (NCT05806671)
    Phase 2
    Tianjin Medical University Cancer Institute and...
    Not yet recruiting
    Last update posted :
    04/10/2023
    Initiation :
    05/01/2023
    Primary completion :
    01/01/2025
    Completion :
    12/01/2025
    HER-2 • ER • PGR
    |
    ER positive
    |
    Irene (pyrotinib) • fulvestrant • AiRuiKang (dalpiciclib)
    Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer (NCT05800756)
    Phase 2
    Yantai Yuhuangding Hospital
    Recruiting
    Last update posted :
    04/06/2023
    Initiation :
    08/04/2022
    Primary completion :
    05/31/2024
    Completion :
    07/30/2025
    ER • PGR
    |
    HER-2 positive • ER positive • PGR positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • letrozole • AiRuiKang (dalpiciclib)
    A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer. (NCT05792410)
    Phase 1/2
    Jiangsu HengRui Medicine Co., Ltd.
    Not yet recruiting
    Last update posted :
    03/31/2023
    Initiation :
    04/01/2023
    Primary completion :
    02/27/2024
    Completion :
    02/27/2025
    HER-2
    |
    Avastin (bevacizumab) • fulvestrant • letrozole • anastrozole • trastuzumab rezetecan (SHR-A1811) • AiRuiKang (dalpiciclib)
    Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer (NCT05638594)
    Phase 2
    Shengjing Hospital
    Recruiting
    Last update posted :
    03/20/2023
    Initiation :
    12/20/2022
    Primary completion :
    12/10/2025
    Completion :
    12/10/2027
    HER-2 • ER
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • Irene (pyrotinib) • letrozole • AiRuiKang (dalpiciclib)
    Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer (PLEASURABLE) (NCT03772353)
    Phase 1/2
    Fudan University
    Active, not recruiting
    Last update posted :
    03/07/2023
    Initiation :
    05/12/2019
    Primary completion :
    06/10/2023
    Completion :
    12/10/2025
    ER • PGR
    |
    HER-2 positive • PGR expression
    |
    Irene (pyrotinib) • fulvestrant • letrozole • AiRuiKang (dalpiciclib)
    mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer (FIND) (NCT05480280)
    Phase 2a
    Sixth Affiliated Hospital, Sun Yat-sen University
    Recruiting
    Last update posted :
    02/28/2023
    Initiation :
    07/20/2022
    Primary completion :
    12/01/2023
    Completion :
    12/01/2023
    KRAS
    |
    KRAS wild-type • RAS wild-type • NRAS wild-type
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • AiRuiKang (dalpiciclib)
    Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer (ZYYY-BC-001) (NCT04997798)
    Phase 2
    First Affiliated Hospital of Zhejiang University
    Recruiting
    Last update posted :
    02/20/2023
    Initiation :
    09/01/2022
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    HER-2 • ER
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • letrozole • exemestane • AiRuiKang (dalpiciclib)
    Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC (NCT05721443)
    Phase 2
    Shanghai Ninth People's Hospital Affiliated to ...
    Recruiting
    Last update posted :
    02/10/2023
    Initiation :
    04/01/2023
    Primary completion :
    01/01/2024
    Completion :
    01/01/2026
    PD-L1 • CDK4
    |
    Erbitux (cetuximab) • AiRuiKang (dalpiciclib)
    Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study (NCT05586841)
    Phase 1
    Beijing 302 Hospital
    Not yet recruiting
    Last update posted :
    10/19/2022
    Initiation :
    11/01/2022
    Primary completion :
    11/30/2024
    Completion :
    11/30/2025
    HER-2
    |
    HER-2 negative
    |
    Epidaza (chidamide) • AiRuiKang (dalpiciclib)
    Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower) (NCT05577923)
    Phase 2
    Fudan University
    Not yet recruiting
    Last update posted :
    10/13/2022
    Initiation :
    11/01/2022
    Primary completion :
    09/01/2024
    Completion :
    03/01/2026
    HER-2 • ER
    |
    ER positive • HER-2 amplification • HER-2 negative
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • fulvestrant • AiRuiKang (dalpiciclib)
    Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC (Shengjing-LCG011) (NCT05228951)
    Phase 2
    Shengjing Hospital
    Recruiting
    Last update posted :
    09/13/2022
    Initiation :
    02/10/2022
    Primary completion :
    12/31/2022
    Completion :
    12/31/2027
    HER-2 • ER • PGR
    |
    EGFR positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • letrozole • AiRuiKang (dalpiciclib)
    Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer (NCT05512416)
    Phase 2
    The Affiliated Hospital of Qingdao University
    Not yet recruiting
    Last update posted :
    08/23/2022
    Initiation :
    08/01/2022
    Primary completion :
    08/01/2023
    Completion :
    05/01/2024
    HER-2 • ER
    |
    HER-2 negative
    |
    letrozole • AiRuiKang (dalpiciclib)
    Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer (NCT05512780)
    Phase 2
    Hebei Medical University Fourth Hospital
    Not yet recruiting
    Last update posted :
    08/23/2022
    Initiation :
    09/10/2022
    Primary completion :
    08/10/2023
    Completion :
    08/10/2024
    HER-2 • ER
    |
    ER positive • HER-2 negative • PGR expression
    |
    letrozole • AiRuiKang (dalpiciclib)
    the Efficacy and Safety of Dalpiciclib Combined With Third-generation EGFR-TKI in Patients With EGFR Mutation and Meningial Metastasis in Non-small Cell Lung Cancer Progressing Through Third-generation TKI and Platinum-containing Two-drug Chemotherapy (NCT05497076)
    Phase N/A
    Fujian Cancer Hospital
    Not yet recruiting
    Last update posted :
    08/11/2022
    Initiation :
    09/01/2022
    Primary completion :
    01/01/2024
    Completion :
    07/01/2024
    CDKN2A • RB1 • CCND1 • CCNE1 • CDK4 • CDKN2B • CCND2 • CCND3
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 18 mutation
    |
    AiRuiKang (dalpiciclib)
    FUSCC Refractory TNBC Umbrella (FUTURE) (NCT03805399)
    Phase 1/2
    Fudan University
    Recruiting
    Last update posted :
    08/10/2022
    Initiation :
    10/18/2018
    Primary completion :
    12/01/2022
    Completion :
    12/01/2022
    HER-2
    |
    HER-2 expression • PGR expression
    |
    everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • Irene (pyrotinib) • albumin-bound paclitaxel • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • Airui'en (rezvilutamide)
    Pyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial (MUKDEN 01) (NCT04486911)
    Phase 2
    Shengjing Hospital
    Active, not recruiting
    Last update posted :
    08/02/2022
    Initiation :
    07/27/2020
    Primary completion :
    12/01/2026
    Completion :
    12/30/2026
    HER-2 • ER • PGR
    |
    EGFR positive
    |
    Irene (pyrotinib) • letrozole • AiRuiKang (dalpiciclib)
    Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (MULAN) (NCT04355858)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    07/26/2022
    Initiation :
    05/01/2020
    Primary completion :
    05/01/2023
    Completion :
    04/01/2025
    HER-2 • ER • PGR
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    Avastin (bevacizumab) • everolimus • AiRuiKa (camrelizumab) • capecitabine • Irene (pyrotinib) • albumin-bound paclitaxel • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • retlirafusp alfa (SHR-1701) • famitinib (SHR 1020) • SHR-2554 • SHR7390 • Airui'en (rezvilutamide)
    Dalpiciclib Plus Letrozole and Capecitabine (NCT05469750)
    Phase 2
    Fujian Medical University Union Hospital
    Not yet recruiting
    Last update posted :
    07/22/2022
    Initiation :
    08/10/2022
    Primary completion :
    08/01/2023
    Completion :
    08/01/2024
    HER-2 • ER • PGR
    |
    HR positive • HER-2 negative
    |
    capecitabine • letrozole • AiRuiKang (dalpiciclib)